Page 96 - 《中国药房》2023年7期

决奈达隆的药物不良反应文献分析
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上官可可 ，曹曼卿 ，王荣环 （1.天津医科大学第二医院药学部，天津 300202；2.天津医科大学肿瘤医院乳
腺外科，天津 300202）
中图分类号 R972+.2 文献标志码 A 文章编号 1001-0408（2023）07-0854-05
DOI 10.6039/j.issn.1001-0408.2023.07.16

摘 要 目的 分析决奈达隆药物不良反应（ADR）的临床表现及特点，为临床安全用药提供参考。方法 计算机检索PubMed数
据库、万方数据、中国知网、维普网自建库起至2022年8月31日收录的决奈达隆ADR的案例报道，对案例中患者年龄、性别、国籍，
决奈达隆的用法用量，ADR发生的时间分布、临床表现、治疗措施及转归情况等进行回顾性分析。结果 共纳入案例报道26篇，合
计27例患者。患者年龄41～86岁，平均年龄为68.8岁，其中60～79岁年龄段发生ADR较多（20例，74.1％）。男性（14例）与女性
（13例）数量相差不大。患者来源于6个国家，美国最多（16例，59.3％）。14例患者用法用量为400 mg，bid；1例为200 mg，bid；12
例患者未明确用法用量。用药1个月内ADR发生率较高（16例，59.3%），其中11例发生于1周内（40.7%），无用药12个月以上的
ADR报道。ADR累及系统器官以肝胆疾病（7例次，23.3％），皮肤和皮下组织疾病（6例次，20.0%），呼吸道、胸膈和纵隔疾病（5例
次，16.7%）为主，此外还包括心脏疾病、肾脏和泌尿系统疾病、血管病、医学检查、眼部疾病。27例患者中，3例发生死亡，其不良反
应分别为闭塞性细支气管炎伴机化性肺炎、中毒性表皮坏死松解症、肝功能衰竭；1例进行了肝移植。结论 决奈达隆存在多器官
系统的ADR，用药前需完善包括心电图、肝功能、肺功能等检查；用药1个月内应加强用药监测，尤其是肝胆、皮肤、呼吸道系统的
ADR。其严重ADR的发生与用药时间长短无明显关系，需要持续进行药学监护和随访，以确保患者临床用药安全。
关键词 决奈达隆；不良反应；文献分析；闭塞性细支气管炎伴机化性肺炎；中毒性表皮坏死松解症；肝功能衰竭

Literature analysis of adverse drug reactions induced by dronedarone
SHANGGUAN Keke ，CAO Manqing ，WANG Ronghuan（1. Dept. of Pharmacy，the Second Hospital of Tianjin
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Medical University，Tianjin 300202，China；2. Dept. of Breast Surgery，Tianjin Medical University Cancer
Institute&Hospital，Tianjin 300202，China）

ABSTRACT OBJECTIVE To analyze the clinical manifestations and characteristics of adverse drug reactions （ADR） induced by
dronedarone，and to provide reference for clinically safe drug use. METHODS Retrieved from PubMed database， Wanfang
database，CNKI and VIP （up to August 31st， 2022），ADR cases of dronedarone were analyzed retrospectively in respect of
patient’s age，gender，nationality，usage and dosage of dronedarone，and occurrence time，clinical manifestations，treatment measures
and outcome of ADR，etc. RESULTS A total of 26 case reports were included，with a total of 27 patients. The age of the patients
was 41-86 years old，with an average age of 68.8 years. The proportion of patients aged 60-79 was the largest （20 cases，74.1%）.
There was no significant difference in the number of males （14 cases） and females （13 cases）. The patients came from 6 countries，
of which the United States was the largest （16 cases，59.3%）. The dosage of 14 patients was 400 mg bid；one patient was 200 mg
bid；the dosage for 12 patients was not specified. The most ADR cases （16 cases，59.3%） occurred within 1 month，of which 11
cases（40.7%） occurred within 1 week，and there were no ADR reports with medication more than 12 months. Organs/systems
involved in ADRs were mainly liver and biliary diseases （7 case times，23.3%），skin and subcutaneous tissue diseases （6 case times，
20.0%），respiratory tract，thoracic and mediastinal diseases （5 case times，16.7%）. In addition，ADR also occurred in heart diseases，
kidney and urinary system diseases，vascular diseases，medical examinations and eye diseases. Among 27 patients，there were 3 cases
of death，the ADR were bronchiolitis obliterans with organizing pneumonia，toxic epidermal necrolysis and hepatic failure，
respectively. One patient underwent liver transplantation. CONCLUSIONS Dronedarone can cause multiple organ system ADR.
Before use，it is necessary to improve the examination including ECG，liver function，lung function，etc. and strengthen drug use
monitoring within one month after the start of use，especially the ADR of hepatobiliary，skin and respiratory system. The occurrence
of severe ADR has no obvious relationship with the duration of medication； even if it is taken safely for a long time，it still needs
continuous pharmaceutical monitoring and follow-up to ensure
Δ 基金项目 国家自然科学基金资助项目（No.82103642） the clinical medication safety of patients.
＊第一作者 主管药师，硕士。研究方向：临床药学。电话：022- KEYWORDS dronedarone； adverse drug reaction； literature
88329039。E-mail：shguk@126.com analysis； bronchiolitis obliterans with organizing pneumonia；
# 通信作者 副主任药师。研究方向：临床药学、药事管理。电话： toxic epidermal necrolysis； hepatic failure
022-88328604。E-mail：wrh1964@126.com

· 854 · China Pharmacy 2023 Vol. 34 No. 7 中国药房 2023年第34卷第7期